IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, … (NCT07483567) | Clinical Trial Compass
Not Yet RecruitingPhase 2
IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
China90 participantsStarted 2026-03-30
Plain-language summary
This study is a prospective, randomized, open, multicenter phase II clinical trial. It plans to enroll 70 participants with locally advanced gastric and gastroesophageal junction adenocarcinoma (G/GEJ AC) who are assessed as suitable for D2 radical surgery and capable of R0 resection.To evaluate the clinical efficacy and tolerability of IBI343 in combination with sintilimab and SOX regimen for perioperative treatment of resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma.Enroll patients who are CLDN18.2 positive.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent and able to comply with the visit and related procedures as specified in the protocol.
✓. Male or female, 18 years ≤ age ≤ 75 years;
✓. ECOG score 0-1;
✓. Histologically confirmed, previously untreated patients with gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction; only Siewert II/III type participants are allowed for gastroesophageal junction cancer;
✓. Clinical staging based on enhanced CT/MRI examination, clinical stage T3\~4a with positive lymph nodes, and no distant metastasis;
✓. The research center and surgeon can perform radical D2 lymph node dissection surgery, R0 resection;
✓. Physical condition and organ function allow for major abdominal surgery;
✓. Confirmed CLDN18.2 expression by central laboratory pathological tissue testing.
Exclusion criteria
✕
What they're measuring
1
Pathological complete response rate (pCR rate): defined as the proportion of participants who, after surgery, show complete regression of tumor cells in the primary lesion and lymph node lesions according to pathological examination.
Timeframe: Up to 4 years
2
Dose-limiting toxicity (DLT), to determine MTD and/or RP2D
✕. Currently participating in another interventional clinical study, except for those in the follow-up phase of an interventional study.
✕. Previous use of traditional Chinese medicine, Chinese patent medicines, or immunomodulators must be ≥2 weeks before starting the study medication.
✕. Received treatment with a strong CYP3A4 inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug.
✕. Received any live vaccine within 4 weeks prior to the first dose of the study drug or plans to receive any during the study period.
✕. Underwent major surgery (craniotomy, thoracotomy, laparotomy, laparoscopic resection of significant tissues or organs, or other as defined by the investigator, excluding needle biopsies) within 4 weeks prior to the first dose of the study drug, or has unhealed wounds, ulcers, or fractures.
✕. Patients who received steroids (\>10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days before enrollment. However, patients are allowed to enroll if they use topical or inhaled steroids, or adrenal replacement therapy with ≤10 mg/day prednisone equivalent, without active autoimmune disease.
✕. History of interstitial lung disease, non-infectious pneumonia, severely impaired pulmonary function, or uncontrolled pulmonary disease such as pulmonary fibrosis, severe radiation pneumonitis, acute lung injury, etc., or suspected of having such conditions during the screening period.